The pathogenesis of osteoarthritis involves multiple etiologies, including mechanical, biochemical, and genetic factors that contribute to the imbalance in the synthesis and destruction of articular cartilage. Pro-inflammatory cytokines such as interleukin-1beta (IL-1beta or IL-1β) and tumor necrosis factor-a are the predominant proinflammatory and catabolic cytokines involved in disease initiation and progression. Other proinflammatory cytokines may amplify or modulate this process, whereas anti-inflammatory cytokines, which are often detected in osteoarthritis tissues, may counteract the tissue destruction and inflammation.
Interleukin-1β plays a key role in the pathology of osteoarthritis or intervertebral disc generation/prolapse. The biological antagonist, interleukin-1 receptor antagonist (IL-1Ra), intervenes in the physiological mechanism of these diseases.
Systems and methods of producing serum and compositions with enhanced IL-1Ra are known in the art. For example, a system and method of producing autologous IL-1Ra in an efficient manner are disclosed in U.S. Pat. No. 8,460,227 issued Jun. 11, 2013, the disclosure of which is incorporated by reference in its entirety herewith. The RAP II device disclosed in U.S. Pat. No. 8,460,227 provides anti-inflammatory cytokines for treatment of human or non-human damaged tissue such as cartilage and neurological tissue, specifically IL-1Ra. Blood is withdrawn from the patient and then transferred into a special container provided with a cap configured to allow the patient's blood to flow on an inner side of the container, to ensure maximum contact with the increased surface area sides of the container. The container is then incubated and centrifuged. Subsequent to the incubation and the centrifugation, the serum containing autologous IL-1Ra is withdrawn and injected back into the patient. Although the serum obtained with the TRAP II device has a high concentration of interleukin-1 receptor antagonist (IL-1Ra), the serum also has a high concentration of interleukin 1-beta (IL-1β) and, thus, an overall low IL-1Ra/IL-1β ratio.
There is a need for devices and methods for specific protein capture to promote healing responses in vivo and healing of tissue injuries. Also needed are methods and devices for selectively removing (filtering out) unwanted components (products, byproducts and/or specific output of cells) from compositions such as, e.g., autologous fluid or serum. Systems and methods of producing serum that has a high concentration of interleukin-1 receptor antagonist (IL-1ra) and reduced interleukin IL-1β (IL-1β) so that the IL-1Ra inhibits the catabolic effects of IL-1β in vivo are also needed. A device that minimizes IL-1β delivered to the damaged tissue by selectively removing the cytokine and, thus, that increases the overall IL-1Ra/IL-1β ratio is also needed.